|Company:||Gloucester Seafood, Inc.|
|Issuer:||Baltimore District Office|
|Issued:||March 23, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Food and Drug Administration
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
March 23, 2007
Mr. Byron H. Delavan, Jr., President
Gloucester Seafood, Inc.
9827 Ditchbank Road
Maryus, Virginia 23061-3622
Dear Mr. Delavan:
We inspected your seafood processing facility, located at 9827 Ditchbank Road, Maryus, Virginia, on January 16-22, 2007. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g). failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your ready-to-eat crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov .
Your significant violations were as follows:
You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for fresh cooked crabmeat and repacked crabmeat both list inadequate critical limits at the refrigerated storage critical control point.
Your fresh cooked crabmeat HACCP plan lists a critical limit, "> [redacted] F for > [redacted] hours maximum cooler conditions," at the Refrigerated Storage critical control point that is not adequate to control pathogen growth. We recommend that you continuously maintain your cooler temperature at or below 40° F. In order to ensure maintenance of proper refrigeration temperatures, we also recommend that processors adopt methods that provide a continuous recording of refrigerated temperatures during refrigeration, e.g. recorder thermometer with a visual check of the instrument at least once a day.
Your repacked crabmeat HACCP plan lists a critical limit, "presence/absence of ice > [redacted] F for [redacted] hours maximum cooler conditions" at the refrigerated storage critical control point that is not adequate to control pathogen growth. This appears to be an in-process/holding step because during our inspection, our investigator observed you storing canned crabmeat in your cooler prior to repackaging. As such, because this canned crabmeat poses a hazard for Clostridium botulinum toxin formation your critical limits at this refrigerated storage step need to control this food safety hazard. Therefore, your critical limit should ensure that the canned crabmeat is stored continually at or below 38° F.
You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the growth of pathogenic bacteria when your process for fresh crabmeat deviated from your critical limit at the "Picking, Boning, Packing" critical control point. A review of your HACCP monitoring records shows that on multiple days you exceeded your critical limit of three and one-half hours. This observation was also seen during our August 2006 inspection.
You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces; prevention of cross contamination; and protection of food, food packaging material, and food contact surfaces from adulteration with cleaning and sanitizing agents with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
• poly barrels which cannot be properly cleaned and sanitized before use being used to transfer cooked ready-to-eat (RTE) crabs into the picking area have deep grooves containing organic material;
• stainless steel picking tables were not cleaned and sanitized at least every four hours during the picking of RTE crabs;
• the ceiling in the picking room for the RTE crabs has areas of flaking paint and mildew above picking tables containing RTE crabmeat.
• an employee delivering cooked RTE crabs to the pickers was observed to set the barrel containing the crabs on top of the picking table where RTE crabs were being processed. The bottom of the barrel was in contact with a wheeled dolly that was not cleaned; and
• cleaning and sanitizing agents were stored in the processing area for RTE crabs during crabmeat production. This was a repeat observation from August 2006.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417
Acting District Director